RECRUITING

Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)

Conditions

Hypertension Hypertension,Essential Renal denervation Neurolysis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To obtain an assessment of the efficacy and safety of renal denervation by dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter in hypertensive subjects in the absence of antihypertensive medications.

Official Title

A Prospective Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation Using the Dehydrated Alcohol Injection, USP Administered With the Peregrine System™ Infusion Catheter in Subjects With Hypertension, in the Absence of Antihypertensive Medications

Quick Facts

Study Start:2025-09-01

Study Completion:2027-10-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07083765

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Has 2 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥150 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg. 2. Documented history of uncontrolled hypertension and is currently taking 1 or 2 antihypertensive medications. 3. Is willing to discontinue any current antihypertensive medications for at least 13 weeks (5-week pre-procedure and 8-week post-procedure). 4. Has a mean 24-hour ambulatory SBP of ≥140 mmHg and ≤170 mmHg with required valid readings.	1. Has renal artery anatomy abnormalities. 2. Has previously undergone renal denervation. 3. Has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy. 4. Has documented untreated sleep apnea. 5. Has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association \[NYHA\] Class III or IV), chronic atrial fibrillation (defined as at least one documented episode in the 12 months before study entry), and known primary pulmonary hypertension (\>60 mmHg pulmonary artery or right ventricular systolic pressure). 6. Is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only). 7. Is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed. 8. Has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.

Inclusion Criteria

Exclusion Criteria

1. Has 2 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥150 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg.
2. Documented history of uncontrolled hypertension and is currently taking 1 or 2 antihypertensive medications.
3. Is willing to discontinue any current antihypertensive medications for at least 13 weeks (5-week pre-procedure and 8-week post-procedure).
4. Has a mean 24-hour ambulatory SBP of ≥140 mmHg and ≤170 mmHg with required valid readings.

1. Has renal artery anatomy abnormalities.
2. Has previously undergone renal denervation.
3. Has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy.
4. Has documented untreated sleep apnea.
5. Has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association \[NYHA\] Class III or IV), chronic atrial fibrillation (defined as at least one documented episode in the 12 months before study entry), and known primary pulmonary hypertension (\>60 mmHg pulmonary artery or right ventricular systolic pressure).
6. Is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
7. Is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed.
8. Has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.

Contacts and Locations

Study Contact

Missy Broich

CONTACT

+1 (650) 688-9743

mbroich@ablativesolutions.com

Debbie Reynolds, PhD

CONTACT

+1 (650) 688-9743

dreynolds@ablativesolutions.com

Principal Investigator

Michael Weber, MD

PRINCIPAL_INVESTIGATOR

SUNY Downstate Medical Center and College of Medicine

David Kandzari, MD

PRINCIPAL_INVESTIGATOR

Piedmont Healthcare

Felix Mahfoud, Prof.Dr. med

PRINCIPAL_INVESTIGATOR

University of Basel

Atul Pathak, Prof.

PRINCIPAL_INVESTIGATOR

Princess Grace Hospital, Monaco

Study Locations (Sites)

Tennova Turkey Creek Medical Center

Knoxville, Tennessee, 37934

United States

Collaborators and Investigators

Sponsor: Ablative Solutions, Inc.

Michael Weber, MD, PRINCIPAL_INVESTIGATOR, SUNY Downstate Medical Center and College of Medicine
David Kandzari, MD, PRINCIPAL_INVESTIGATOR, Piedmont Healthcare
Felix Mahfoud, Prof.Dr. med, PRINCIPAL_INVESTIGATOR, University of Basel
Atul Pathak, Prof., PRINCIPAL_INVESTIGATOR, Princess Grace Hospital, Monaco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-01

Study Completion Date2027-10-31

Study Record Updates

Study Start Date2025-09-01

Study Completion Date2027-10-31

Terms related to this study

Keywords Provided by Researchers

Renal denervation
Neurolysis

Additional Relevant MeSH Terms

Hypertension
Hypertension,Essential